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In re Smith & Nephew Birmingham HIP Resurfacing (BHR) HIP Implant Products Liability Litigation

United States District Court, D. Maryland

August 5, 2019





         Pending before the court is Smith & Nephew's motion to dismiss claims in the THA track. The motion boils down to one core dispute: how does the express preemption provision of the Medical Device Amendments of 1976 (the "MDA") apply to hybrid systems that are comprised of both premarket-approved and § 510(k)-approved components? The Fourth Circuit has yet to address this question, and resolving the issue calls for careful consideration of the interrelated, and sometimes competing, concerns that underlie the U.S. Food and Drug Administration's (the "FDA") premarket. approval process and the MDA's preemption provision-namely, ensuring public safety while encouraging innovation. For the reasons outlined below, Smith & Nephew's motion will be granted in part and denied in part.


         Smith & Nephew seeks to dismiss claims in two of the plaintiffs' Master Amended Consolidated Complaints ("MACCs"). First, the plaintiffs filed a MACC that alleges harm from the use of Smith & Nephew's Birmingham Hip Resurfacing ("BHR") cup with Smith & Nephew's cobalt-chrome modular femoral heads as part of total hip arthroplasties ("THA"). (MACC ["THA MACC], ECF No. 878). Second, the plaintiffs filed a MACC that alleges harm from the use of Smith & Nephew's R3 metal liner during THAs with a metal modular femoral head and/or with the R3 acetabular shell. (MACC ["R3 MACC"], ECF No. 966). Following the parties' lead, and for the sake of efficiency, the court will refer to these two hybrid systems as the BHR-THA and the R3-THA systems.

         The plaintiffs allege that Smith & Nephew was aware of the dangers posed by metal-on-metal devices, which create "metal wear debris" over time. (THA MACC ¶¶ 23-31, 40-54; R3 MACC ¶¶ 47-53). The metal ions produced from this wear-and-tear are toxic, can destroy human tissue, and often lead to the failure of the hip implant, requiring revision surgery. (THA MACC ¶¶ 23-24, 32-34). Despite this risk, the plaintiffs allege Smith & Nephew promoted the use of the BHR cup with metal modular femoral heads and stems and the use of the R3 metal liner with the R3 acetabular shell well after competitor products were withdrawn from the market. (THA MACC ¶¶ 36; R3 MACC ¶¶ 63-65). The plaintiffs further allege that Smith & Nephew made public statements implying that the BHR-THA and R3-THA systems were safe, (THA MACC ¶¶ 59, 79, 81, 83; R3 MACC ¶¶ 15-16), publicly indicated that the R3 metal liner could be used with the R3 acetabular system, (R3 MACC ¶ 15), promoted both the BHR-THA and the R3-THA systems through its sales representatives, (see e.g., THA MACC ¶ 121; R3 MACC ¶¶ 17-20, 38), circulated information to physicians that implied the BHR-THA and R3-THA systems were safe, and withheld critical safety and efficacy information from physicians, (see e.g., THA MACC ¶¶ 61, 63-64, 68-69, 284-85; R3 MAC ¶¶ 23, 37-38, 40, 81, 88-89).

         The plaintiffs allege that Smith & Nephew promoted the BHR-THA and R3-THA systems even though the FDA refused to certify the safety of either system through the premarket approval process. (THA MACC ¶¶ 63, 70; R3 MACC ¶¶ 9, 14). In fact, the FDA explicitly indicated that the metal modular femoral heads were intended for use with a "natural acetabular" to avoid the release of metal debris that can occur from metal-on-metal devices, (THA MACC ¶ 97), and the FDA stated that the "R3 metal liner should not be used with the R3 acetabular shell," (R3 MACC ¶¶ 9, 11). Patients who received the BHR-THA and R3-THA systems suffered adverse reactions and underwent revision surgeries. (See, e.g., .THA MACC ¶ 32; R3 MACC ¶¶ 60, 65).

         In its motion to dismiss, Smith & Nephew sets forth several arguments: (1) the plaintiffs' strict liability, implied warranty, misrepresentation, deceptive trade practices, and fraudulent concealment arguments are preempted by the MDA; (2) several of the plaintiffs' claims are not pled with the particularity required by Rule 8 and Rule 9(b); and (3) the court should reconsider its ruling in the BHR track that several of the plaintiffs' claims at least superficially survive preemption.


         When ruling on a motion under Rule 12(b)(6), the court must "accept the well-pled allegations of the complaint as true," and "construe the facts and reasonable inferences derived therefrom in the light most favorable to the plaintiff." Ibarra v. United States, 120 F.3d 472, 474 (4th Cir. 1997). "Even though the requirements for pleading a proper complaint are substantially aimed at assuring that the defendant be given adequate notice of the nature of a claim being made against him, they also provide criteria for defining issues for trial and for early disposition of inappropriate complaints." Francis v. Giacomelli, 588 F.3d 186, 192 (4th Cir. 2009). "The mere recital of elements of a cause of action, supported only by conclusory statements,, is not sufficient to survive a motion made pursuant to Rule 12(b)(6)." Walters v. McMahen, 684 F.3d 435, 439 (4th Cir. 2012) (citing Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)). To survive a motion to dismiss, the factual allegations of a complaint "must be enough to raise a right to relief above the speculative level on the assumption that all the allegations in the complaint are true (even if doubtful in fact)." Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007) (internal citations omitted). "To satisfy this standard, a plaintiff need not 'forecast' evidence sufficient to prove the elements of the claim. However, the complaint must allege sufficient facts to establish those elements." Walters, 684 F.3d at 439 (citation omitted). "Thus, while a plaintiff does not need to demonstrate in a complaint that the right to relief is 'probable,' the complaint must advance the plaintiffs claim 'across the line from conceivable to plausible.'" Id. (quoting Twombly, 550 U.S. at 570).


         The Medical Device Amendments of 1976

         In 1976, in response to "mounting consumer and regulatory concern" about the health risks posed by new medical devices, the FDA passed the MDA. Medtronic, Inc. v. Lohr, 518 U.S. 470, 475-76 (1996); Riegel v. Medtronic, Inc., 522 U.S. 312, 315-16 (2018). Expanding the scope of the Federal Food, Drug, and Cosmetic Act (the "FDCA"), the MDA established federal requirements for the introduction of new devices and included an express preemption provision that preempts conflicting state law. See Medical Device Amendments of 1976, Pub. L. No. 94-295, sec. 2, §§ 513-516, 521, 90 Stat. 539, 540-60, 562 (codified as amended at 21 U.S.C. §§ 360c-360f, 360k). The MDA established three classes of medical devices, tiering devices based upon the potential risk posed to human health: Class I, Class II, and Class III. 21 U.S.C. § 360c. Class I medical devices are the most benign, while Class III medical devices pose the most potential risk to human life and welfare and, therefore, are subject to the most stringent regulations. Id.; see Riegel, 522 U.S. at 317.

         Premarket Approval Process

         Before a manufacturer can release a Class III device to the public, it must proceed through the premarket approval ("PMA") process. See 21 U.S.C. § 360c(a)(1)(C). A device will receive premarket approval only if the FDA determines, after considering "any probable benefit to health from the use of the device against any probable risk of injury or illness from such use," that "there is a 'reasonable assurance' of the device's 'safety and effectiveness.'" Riegel, 552 U.S. at 318 (quoting 21 U.S.C. §§ 360c(a)(2)(C), 360e(d)). The premarket approval process is demanding. On average, before rendering a decision on any Class III device, the FDA spends 1, 200 hours reviewing the manufacturer's submissions and data related to the device's safety and efficacy. Lohr, 518 U.S. at 477 (first citing Hearings before the Subcommittee on Health and the Environment of the House Committee on Energy & Commerce, 100th Cong., 1st Sess. (Ser. No. 100-34), p. 384 (1987) (hereinafter 1987 Hearings), and then citing Kahan, Premarket Approval Versus Premarket Notification: Different Routes to the Same Market, 39 FOOD DRUG Cosm. L.J. 510, 512-14(1984)).

         Manufacturers must provide the FDA with a range of information, including "a full statement of the [device's] components, ingredients, and properties," 21 U.S.C. § 360e(c)(1)(B); Riegel, 552 U.S. at 317-18, and a "specimen of the proposed labeling" that details "conditions of use," Riegel, 552 U.S. at 318; 21 U.S.C. § 360e(c)(1)(F). The FDA also reviews the manufacturer's proposed labeling to ensure that it is not false or misleading. Riegel, 552 U.S. at 318; 21 U.S.C. § 360e(d)(1)(A). "Once approved, the device may be manufactured, advertised, and distributed to the public, but those marketing activities may not be done in a manner 'inconsistent with ... the [premarket] approval order for the device.'" Shaker v. Smith & Nephew, PLC, 885 F.3d 760, 766 (2018) (quoting 21 C.F.R. § 814.80).

         And manufacturers are required to inform the FDA of "new clinical investigations or scientific studies concerning the device which the [manufacturer] knows of or reasonably should know of," and to "report incidents in which the device may have caused or contributed to death or serious injury." Riegel, 552 U.S. at 319 (first citing 21 C.F.R. § 814.84(b)(2), and then citing § 803.50(a)). Manufacturers of premarket-approved products are also required to investigate adverse reports to determine if remedial action is required to prevent substantial harm to the public health, 21 C.F.R. § 803.50, and to report these findings to the FDA within five days, 21 C.F.R. § 803.53. If manufacturers want to make changes to a PMA approved device, they must submit an application for "supplemental premarket approval" to the FDA. § 360e(d)(5); 21 C.F.R. § 814.39(c). Finally, the FDA may withdraw premarket approval if it "determines that a device is unsafe or ineffective." Riegel, 552 U.S. at 319-20 (first citing § 360e(e)(1), and then citing § 360h(e)).

         Importantly, however, not all Class III devices are approved through the PMA process. The MD A provides for two exceptions to the PMA requirement. First, the MDA allowed devices which were already on the market as of 1976 to "remain on the market without FDA approval until such time as the FDA initiates and completes the requisite PMA." Lohr, 518 U.S. at 478 (first citing 21 U.S.C. § 360e(b)(1)(A), and then citing 21 C.F.R. § 814.1(c)(1) (1995)). "Second, to prevent manufacturers of grandfathered devices from monopolizing the market while new devices clear the PMA hurdle, and to ensure that improvements to existing devices can be rapidly introduced into the market, the Act [] permits devices that are 'substantially equivalent' to pre-existing devices to avoid the PMA process." Lohr, 518 U.S. at 478 (citing 21 U.S.C. § 360e(b)(1)(B)). This approval process for substantially equivalent devices, described in further detail below, is known as the § 510(k) process. See 21 U.S.C. § 360(k).

         § 510 (k) Approval Process

         Today, many Class I, II, and III devices are reviewed through the comparatively lenient §510(k) process. See 21 U.S.C. § 360(k). On average, the FDA spends a mere 20 hours determining whether to approve a device through the § 510(k) process. Lohr, 518 U.S. at 479 (citing 1987 Hearings, at 384). And clearing the § 510(k) process does not require an independent or exhaustive review of a device's safety and efficacy. Lohr, 518 U.S. at 479; Shuker, 885 F.3d at 767. Instead, manufacturers submit a "premarket notification" to the FDA, and the device may be cleared for the market if it is "substantially equivalent" to an existing device.

         In designing the MDA, Congress expected that most Class III devices would be approved for market through the PMA process. Lohr, 518 U.S. at 479. But because of the comparative ease of receiving approval through the § 510(k) process, many Class III devices enter the market without proceeding through the PMA process. In fact, by 1983, "nearly 1, 000 of approximately 1, 100 Class III devices that had been introduced to the market since 1976" were processed through the § 510(k) process instead of the PMA process. Id. (citing Medical Device Regulation: The FDA's Neglected Child (Committee Print compiled for the Subcommittee on Oversight and Investigations of the House Committee on Energy & Commerce), Comm. Print 98-F, p. 34 (1983)). By 1990, "80% of new Class III devices were being introduced to the market through the § 510(k) process and without PMA review." Lohr, 518 U.S. at 479 (citing H.R.Rep. No. 101-808, p. 14 (1990)).

         In 1990 Congress amended the MDA in an attempt to decrease "the FDA's reliance on the § 510(k) process while continuing to ensure that particularly risky devices received full PMA review." Lohr, 518 U.S. at 479 n.4 (citing Safe Medical Devices Act of 1990, 104 Stat. 4511). Despite these amendments, the § 510(k) approval process continues to be overwhelmingly preferred. In 2005, for example, the FDA approved 3, 148 Class III devices through the § 510(k) process compared to a meager 32 devices through the PMA process. Riegel, 552 U.S. at 317 (citing P. Hutt, R. Merril, & L. Grossman, Food & Drug Law 992 (3d ed. 2007)).[1]

         The MDA's Express Preemption Provision

         Beyond.the differences in rigor between the PMA and § 510(k) approval processes, the processes also impart distinct preemption consequences. The MDA contains an express preemption provision, which reads: "no State .. . may establish or continue in effect with respect to a device... any requirement which is different from, or in addition to," any federal requirement that relates either "to the safety or effectiveness of the device" or "to any other matter" included in a federal requirement applicable to the device. 21 U.S.C. § 360k(a). The Supreme Court has held that premarket approval establishes federal "requirement[s]" under the MDA. Riegel, 552 U.S. at 322-23. By contrast, the § 510(k) process does not establish federal requirements because it "focuse[s] on equivalence, not safety." Id. at 323 (citing Lohr, 518 U.S. at 493). Accordingly, state law may not impose requirements on PMA approved devices that depart from, or expand upon, federal requirements. But parallel state-law claims that mirror the federal requirements established by the MDA are not preempted. Lohr, 518 U.S. at 494-95. Importantly, state claims need not be identical to federal requirements to survive explicit preemption, they need only be "narrower, not broader" than existing federal requirements. See Lohr, 518 U.S. at 495 ("While such a narrower requirement might be 'different from' the federal rules in a literal sense, such a difference would surely provide a strange reason for finding preemption of a state rule insofar as it duplicates the federal rule."); see also id, (Breyer, J., joining the Court's opinion as to Part V).

         Accordingly, determining whether state-law claims are preempted under § 360k(a) requires a two-step analysis: (1) has the federal government established requirements applicable to the specific device?; and (2) if so, do the plaintiffs' state-law claims impose state requirements "with respect to the device that are 'different from, or in addition to,' the federal ones, and that relate to safety and efficacy"? See Riegel, 552 U.S. at 321-22 (quoting 21 U.S.C. § 360k(a)). Claims will be preempted only if both of these questions are answered in the affirmative.

         Implied ...

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